The biotherapies field is expanding quickly, and many new professionals are entering the field in different settings, including academic, commercial and manufacturing. There is a common ground everyone needs to cover as a starting point; this book, Getting Started in Processing for Biotherapies, is meant to offer this ‘starting kit’ for processing. I was inspired to work on it because it enables sharing the knowledge we acquired to support newcomers in the field.
The scope of this publication is to cover all aspects of starting in processing for biotherapies, including business plans, budget and personnel considerations and processing 101. Additional common topics covered include contracted services as well as quality and regularity relevant aspects. The target audience includes professionals who are beginning the work involved with getting started in processing for biotherapies. This may include those involved with new bone marrow transplant (BMT) programs, new immune effector cell therapy (IEC) programs, and manufacturers and commercial entities involved in different phases of processing.
The challenges facilities face when collecting cellular material for biotherapies are mostly related to variations in the requirements of different manufacturers for the different protocols – either with commercially approved products or therapies in clinical trials – as well as less direct and timely feedback on the composition of the collected product from the end-user.
With the expansion of biotherapies to include other indications – such as solid organs tumors, nonmalignant hematological disorders, to mention few – there will be an increased demand for both collection and proceeding abilities to address patient needs. Blood collection facilities typically have an established infrastructure and expertise in those areas and, thus, their role will be increasing and critical to the sustainability and growth of novel biotherapies.
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